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The FDA Must Avoid Policies that Would Inflame the Opioid Crisis

Ross Marchand on 2018-09-17 09:11:00

Last week, the Independent Women’s Forum (IWF) convened an expert discussion panel on the opioid crisis with Jessica Hulsey Nickel (the President & Chief Executive Officer of the Addiction Policy Forum), and Charmaine Yoest (Associate Director at the Office of National Drug Control Policy) in the Executive Office of the President.

Both Nickel and Yoest shared poignant stories about the epidemic which has claimed more than 200,000 lives over the past 20 years.

Both experts agreed that a comprehensive government approach is needed to ensure that the crisis of opioid addiction and abuse is addressed without limiting access to those with legitimate needs for medications.

The conversation underscored the dire seriousness of the situation, but also provided real insight into how the private and non-profit sectors can and are working with government to help end the crisis and get those affected the care and support that they need.

Specifically, one comment from Charmaine Yoest stood out:, the federal government must ensure that opioids are not “entering the U.S. from overseas.”

However, drug importation is a serious proposal under consideration by the Food and Drug Administration (FDA).

The FDA has convened a panel to investigate possible scenarios in which they would permit the importation of foreign pharmaceuticals in an effort to lower the cost of prescription drugs.

While we applaud the administration’s willingness to look at any policy that may help lower costs, importation is not the answer and, particularly when it comes to opioids and drug abuse, could actually harm public health.

The truth is that importing prescription drugs would add unverified drugs into the U.S. supply chain, creating a public health crisis as pharmacies and patients grapple with new uncertainty over what is in their drugs and if the drugs are safe. Essentially, a two-track system of unregulated and regulated drugs would emerge, creating uncertainty and undermining a level playing field in the field of medicine.

According to a report from the World Health Organization, as much as 10 percent of the prescriptions in developing countries are fake.

When importing prescription drugs, it can be difficult (if not impossible) to truly know their origins. From ingredient provenance all the way to shipping and packaging, pharmaceutical manufacturing is far more complicated than compressing ingredients into a pill and, in the United States at least, is highly regulated and tested to ensure the public’s safety.

Nor is this an abstract problem. Faulty drugs kill thousands across the world each year and in, one particularly memorable event, more than 200 people died in Lahore, Pakistan because a pharmacy used cheap and therefore poisonous ingredients.

Given the current opioid crisis, the threat is even larger. Increasing the supply of unverified drugs into the country merely provides another avenue for opioids to enter the United States and counteracts the administrations substantive work to combat drug abuse. It’s a problem already encountered, as counterfeit drugs that are actually opioids are sold as a different medication.

Likewise, in August of this year, the FDA had to reprimand 21 web-based companiesin the United States for marketing “unapproved opioids.” Adding other sources of opioids for Americans already suffering from addiction just makes this problem worse.

It’s encouraging that the White House has made the opioids crisis a top priority and the progress made so far has been encouraging. However, Americans must remain vigilant against policies that could, however inadvertently, undermine these efforts.

Importation of foreign drugs is one such policy, threatening public health and adding fuel to the ongoing opioid crisis. America needs a level playing field undergirded by a reliable regulatory process, not a backdoor channel to shady drugs.